azficel-t

Contraindicated in:

Previous hypersensitivity to azficel-T;
Hypersensitivity to amphotericin, dimethyl sulfoxide (DMSO), gentamicin or materials of bovine origin;
Known history of keloid or excessive scar formation;
Acute local skin infection ( may cause spread).

Use Cautiously in:

Genetic disorders affecting dermal fibroblasts or formation of normal collagen matrices (abnormal responses may occur);
Concurrent immunosuppressants, radiation, chemotherapy or immunomodulatory therapy (↑ risk of infection with ↓ healing);
Concurrent use of anticoagulants (↑ risk of bleeding);
OB: Use in pregnancy only if clearly needed;
Pedi: Safe and effective use in children has not been established.

Adv. Reactions/Side Effects ⬆ ⬇

Local: bruising, edema, erythema, bleeding, dermatitis, irritation, keloid/hypertrophic scarring, nodules, papules, pruritus, redness

Misc: basal cell cancer, herpes labialis, HYPERSENSITIVITY REACTIONS INCLUDING ANALPHYAXIS, vasculitis

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of antineoplastices, immunosuppressants and immunomodulators↑ risk of infection and poor healing.
Concurrent use of anticoagulants↑ risk of bleeding.

Availability ⬆ ⬇

Suspension for autologous intradermal injection: 18 million autologous fibroblasts/1.2 mL sufficient to deliver 1 mL of product

Route/Dosage ⬆ ⬇

Intradermal (Adults ): 0.1 mL/linear centimeter into nasolabial fold wrinkles. Course is three treatment sessions (up to 2 mL/session) at 3–6 wk intervals.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Cells are obtained from patient's post-auricular skin. These dernmal fibroblasts are then prepared and injected into nasolabial folds.

Therapeutic effects:

Classifications ⬆ ⬇

Therapeutic Classification: cosmetic agents

Pharmacologic Classification: autologous cellular products

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(improvement in appearance)

ROUTE	ONSET	PEAK	DURATION
Intradermal	4–5 mo	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and procedure for azficel-T. Inform patient of importance of treatment schedule. If a treatment session is missed, cells will expire and must be thrown out, so new treatment sessions must be scheduled. Also, there is a chance that skin samples will not make enough cells to use. If this occurs, new biopsies may need to be taken.
Advise patient on post-treatment care. Do not apply ice to face; cold compress may be applied for 2–3 minutes at a time, if needed to ease swelling or discomfort. For at least 24 hours, do not wash site of injections. Do not scrub, rub or manipulate treatment area for at least 72 hours. Do not apply any products (make-up, facial creams, sunscreen) to treatment area for 72 hr.
Inform patient of what to expect post-procedure. Expect mild to moderate redness, swelling, puffiness, or bruising following injections. Advise patient to call doctor or emergency department for any persistent or unexpected side effects.
Instruct patient to notify health care provider if fever over 100°F, redness, warmth, or pain at injection or biopsy sites lasts more than 3 days.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.